Guardant Health, Inc. Presents New Data Showing Blood Test Accuracy in Detecting Colorectal Cancer in First-Of-Its Kind Prospective Study At Digestive Disease Week 2022
Guardant Health, Inc. announced data showing its blood-based multimodal test achieved clinically significant thresholds of sensitivity and specificity in detecting colorectal cancer (CRC). These data were presented during an oral presentation at Digestive Disease Week 2022. The assay used in this analysis integrates genomics and epigenomics for CRC detection. An updated version of this assay that incorporates the use of proteomics, Shield™, is now available as a laboratory developed test for eligible individuals by prescription only through healthcare professionals. The ongoing prospective observational study is being conducted at four hospitals in Spain. The data presented include 557 individuals who had a complete colonoscopy and results from the blood-based multimodal CRC test. The median age was 55 years (range 45-84 years; 21% age 45-49, 75% age 50-74, 4% age 75+), and 52% of the cohort was female. Sensitivity (detection rate) for colorectal cancer was determined at 90% and 95% specificity. At 90% specificity the assay achieved 100% sensitivity (8/8; Stage I,1/1; Stage II,3/3; Stage III,2/2; Stage IV,2/2). At 95% specificity, the assay achieved sensitivity for CRC at 88% (7/8): Stage I (1/1), Stage II (2/3), Stage III (2/2), Stage IV (2/2).